Methods of using IL-1 antagonists to treat autoinflammatory disease

Abstract

Methods of treating, inhibiting, or ameliorating an autoinflammatory disorder, disease, or condition in a subject in need thereof, comprising administering to a subject in need a therapeutic amount of an interleukin 1 (IL-1) antagonist, wherein the autoinflammatory disorder, disease, or condition is treated, inhibited, or ameliorated. The IL-1 antagonist is a molecule capable of binding and inhibiting IL-1. The therapeutic methods are useful for treating a human adult or child suffering from Neonatal Onset Multisystem Inflammatory Disorder (NOMID/CINCA), Muckle-Wells Syndrome (MWS), Familial Cold Autoinflammatory Syndrome (FCAS), familial mediterranean fever (FMF), tumor necrosis factor receptor-associated periodic fever syndrome (TRAPS), or systemic onset juvenile idiopathic arthritis (Still's Disease).

What is claimed is: 
     
       1. A method of treating, inhibiting, or ameliorating an autoinflammatory disorder, disease, or condition selected from the group consisting of Neonatal Onset Multisystem Inflammatory Disorder (NOMID/CINCA), Muckle-Wells Syndrome (MWS), Familial Cold Autoinflammatory syndrome (FCAS), familial Mediterranean fever (FMF), tumor necrosis factor receptor-associated periodic fever syndrome (TRAPS), and Still's Disease, the method comprising administering to a subject in need thereof an IL-1 fusion protein antagonist comprising the amino acid sequence of SEQ ID NO:10, as a first therapeutic agent, in a dose range of 100-320 mg on a weekly basis. 
     
     
       2. The method of  claim 1 , wherein the IL-1 fusion protein antagonist is administered subcutaneously, intramuscularly, intravenously, topically, transdermally or orally. 
     
     
       3. The method of  claim 1  further comprising administering one or more additional therapeutic agents selected from the group consisting of a NSAID, an IL-1 fusion protein antagonist that is different from the first therapeutic agent, etanercept (Enbrel®, Amgen), infliximab (Remicade®, Centocor), Humira® (Abbott), thalidomide, a steroid, anakinra (Kineret®, Amgen), colchicine, IL-18BP or a derivative, an IL-18-binding fusion protein, anti-IL-18, anti-IL-18R1, anti-IL-18Racp, aspirin, prednisolone, methotrexate, cyclosporine A, caspase-1, p38, IKK1/2, CTLA-41g, anti-IL-6and anti-IL6Ra. 
     
     
       4. The method of  claim 3 , wherein the first therapeutic agent and the additional therapeutic agent or agents are administered simultaneously. 
     
     
       5. The method of  claim 3 , wherein the first therapeutic agent and the additional therapeutic agent or agents are administered sequentially. 
     
     
       6. The method of  claim 1 , the method comprising administering to the subject in need thereof the IL-1 fusion protein antagonist at a dose of 100 mg, 160 mg, or 320 mg, on a weekly basis. 
     
     
       7. The method of  claim 6 , wherein the IL-1 fusion protein antagonist is administered subcutaneously, intramuscularly, intravenously, topically, transdermally or orally. 
     
     
       8. The method of  claim 6  further comprising administering one or more additional therapeutic agents selected from the group consisting of a NSAID, an IL-1 fusion protein antagonist that is different from the first therapeutic agent, etanercept (Enbrel®, Amgen), infliximab (Remicade®, Centocor), Humira® (Abbott), thalidomide, a steroid, anakinra (Kineret®, Amgen), colchicine, IL-18BP or a derivative, an IL-18-binding fusion protein, anti-IL-18, anti-IL-18R1, anti-IL-18Racp, aspirin, prednisolone, methotrexate, cyclosporine A, caspase-1, p38, IKK1/2, CTLA-41g, anti-IL-6 and anti-IL6Ra. 
     
     
       9. The method of  claim 8 , wherein the first therapeutic agent and the additional therapeutic agent or agents are administered simultaneously. 
     
     
       10. The method of  claim 8 , wherein the first therapeutic agent and the additional therapeutic agent or agents are administered sequentially. 
     
     
       11. The method of  claim 1 , wherein the autoinflammatory disorder, disease, condition is Still's Disease, and the Still's disease is juvenile onset Still's Disease or adult onset Still's Disease.